search
Back to results

Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

Primary Purpose

Renal Insufficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
POSS-PCU vascular graft
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects requiring vascular access for haemodialysis
  • Subjects with no suitable vein.
  • Subjects aged 18 - 80 years old
  • Subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained

  • Patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment:

    • Condom with spermicide.

AND 1 of the following:

  • Oral contraceptive or hormonal therapy (e.g. hormone implants).
  • Placement of an intra-uterine device.

Exclusion Criteria:

  • Subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge)
  • Subjects with left ventricle ejection fraction (LVEF) <20% diagnosed on ECHO either pre-procedure or documented within the previous 3 months prior to consent.
  • Pregnant or lactating
  • Allergies to any constituents of the graft material
  • Patients who are infected or colonized with Methicillin Resistant Staphylococcus Aureus (MRSA).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    POSS-PCU graft

    Arm Description

    POSS-PCU vascular graft will be used to create vascular access for dialysis.

    Outcomes

    Primary Outcome Measures

    Patency rate
    The primary performance end point of the study is the patency rate of the POSS-PCU graft at the end of the 18 months as measured with US Doppler, which will be compared to the known patency rate for the PTFE graft
    Safety endpoint of this study is defined as any Serious Adverse Event related to the implantation procedure or device implantation within 30 days of implantation procedure

    Secondary Outcome Measures

    Patency rate
    Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.
    Secondary patency rate
    Any surgical or endovascular intervention required to maintain the patency of the grafts up to the 18 month time point.

    Full Information

    First Posted
    November 21, 2014
    Last Updated
    April 17, 2020
    Sponsor
    University College, London
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02301312
    Brief Title
    Clinical Study of POSS-PCU Vascular Grafts for Vascular Access
    Official Title
    A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    April 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be enrolled and monitored at regular intervals for 18 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    POSS-PCU graft
    Arm Type
    Experimental
    Arm Description
    POSS-PCU vascular graft will be used to create vascular access for dialysis.
    Intervention Type
    Device
    Intervention Name(s)
    POSS-PCU vascular graft
    Intervention Description
    New vascular access graft
    Primary Outcome Measure Information:
    Title
    Patency rate
    Description
    The primary performance end point of the study is the patency rate of the POSS-PCU graft at the end of the 18 months as measured with US Doppler, which will be compared to the known patency rate for the PTFE graft
    Time Frame
    18 months
    Title
    Safety endpoint of this study is defined as any Serious Adverse Event related to the implantation procedure or device implantation within 30 days of implantation procedure
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Patency rate
    Description
    Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.
    Time Frame
    12 months
    Title
    Secondary patency rate
    Description
    Any surgical or endovascular intervention required to maintain the patency of the grafts up to the 18 month time point.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects requiring vascular access for haemodialysis Subjects with no suitable vein. Subjects aged 18 - 80 years old Subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained Patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment: Condom with spermicide. AND 1 of the following: Oral contraceptive or hormonal therapy (e.g. hormone implants). Placement of an intra-uterine device. Exclusion Criteria: Subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge) Subjects with left ventricle ejection fraction (LVEF) <20% diagnosed on ECHO either pre-procedure or documented within the previous 3 months prior to consent. Pregnant or lactating Allergies to any constituents of the graft material Patients who are infected or colonized with Methicillin Resistant Staphylococcus Aureus (MRSA).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nimrita Verma
    Phone
    020 7679 6159
    Email
    n.verma@ucl.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Janice Tsui, MD FRCS
    Phone
    +44 2077940500
    Ext
    33938
    Email
    janice.tsui@ucl.ac.uk

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28347955
    Citation
    Askari F, Shafieian M, Solouk A, Hashemi A. A comparison of the material properties of natural and synthetic vascular walls. J Mech Behav Biomed Mater. 2017 Jul;71:209-215. doi: 10.1016/j.jmbbm.2017.03.016. Epub 2017 Mar 23.
    Results Reference
    derived

    Learn more about this trial

    Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

    We'll reach out to this number within 24 hrs